Transcatheter aortic valve replacement for severe aortic valve disease
Official title: Transcatheter Aortic Valve Replacement for Severe Aortic Valve Disease: Multi-center, Real-word Registry
Run by Nanjing First Hospital, Nanjing Medical University · NCT05439863 · Data updated 2026-11-12
This study is trying to see how well transcatheter aortic valve replacement works for people with severe aortic valve problems, especially younger patients, and what complications might occur.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 5000 (estimated) |
| Sponsor | Nanjing First Hospital, Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Status | Recruiting |
| Started | July 1, 2022 |
| Main results expected | December 30, 2032 |
| Study ends | December 30, 2037 |
| Registry record updated | November 15, 2024 |
| Trial ID | NCT05439863 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals diagnosed with severe aortic stenosis or aortic regurgitation who are undergoing TAVR.
✕Probably not a fit
Patients who refuse clinical follow-up will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on transcatheter aortic valve replacement (TAVR) as a treatment for severe aortic stenosis and aortic regurgitation. It aims to create a prospective, multicenter database to gather real-world data addressing various clinical questions related to TAVR, such as its effectiveness in younger patients, valve durability, and complications like valve leaflet thrombosis. By analyzing this data, the study seeks to enhance understanding of TAVR outcomes and inform clinical practices.
Why it matters
Potential benefit: If successful, this study could provide valuable insights that improve treatment strategies for patients with severe aortic valve disease.
How similar studies have gone: Previous studies have shown that TAVR can be non-inferior or superior to surgical aortic valve replacement, indicating a promising approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Clinical diagnosis of severe aortic stenosis or aortic regurgitation 2. Patients undergo transcatheter aortic valve replacement Exclusion Criteria: patients refuse the clinical follow-up
Where it's running
-
Nanjing First Hospital
Nanjing, Jiangsu, China Recruiting
Study contacts
- Study coordinator: Jun-Jie Zhang, MD
- Email: jameszll@163.com
- Phone: +86-25-52271350
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
KONECT RESILIA Aortic Valved Conduit real-world use in adults needing valve and ascending aorta replacement
This study tests how the KONECT RESILIA aortic valved conduit performs in adults needing aortic valve and ascending aorta replacement.
-
Savvywire versus standard LV guidewires during transfemoral TAVI
For people 50 and older having transfemoral TAVI, researchers will compare the Savvywire and standard LV guidewires to see if the Savvywire improves pacing and procedure-related blood flow.
-
EmStop Embolic Protection System for TAVR in Aortic Valve Stenosis
This study tests whether the EmStop protective device can safely capture and remove debris during transcatheter aortic valve replacement in adults with severe aortic valve stenosis.
-
Tracking progression and consequences of heart valve disease
This project will follow adults with moderate or worse valve disease to see if clinical tests and imaging can predict when their condition will get worse.
-
Real-world outcomes of the INSPIRIS RESILIA aortic valve in adults
This registry will collect real-world data to see how the INSPIRIS RESILIA aortic valve performs in adults undergoing aortic valve replacement.
-
Transcatheter JenaValve or J-Valve treatment for severe aortic regurgitation
This project will try two transcatheter heart valves (JenaValve and J-Valve) to treat people with severe symptomatic aortic regurgitation who are high risk for open-heart surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.